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A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1

Study acronym: TAGNOT
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Active, Not Recruiting to Recruiting
    • Start date: Oct 24, 2025 to Dec 2, 2025
    • Site details revised at 5 of 5 sites
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
One of the most relevant targets in the field of novel targeted anticancer therapy is the family of receptors to fibroblast growth factor receptors (FGFRs). FGFR1 is the main representative of the FGFR family. The goal of this clinical trial is to learn if monoclonal anti-FGFR1 antibody (OM-RCA-01) works to treat metastatic cancers expressing FGFR1. It will also learn about the safety of drug OM-RCA-01. The main questions it aims to answer are: 1. What medical problems do participants have when receiving drug OM-RCA-01? 2. What dose of the drug should patients receive in the next studies? 3. Does tumor growth slow down in patients receiving OM-RCA-01? All patients in this study will receive the antibody treatment. The drug will be given through a vein (by IV infusion) every two weeks, for as long as the disease remains under control and the treatment is well tolerated.
Trial Details
NCT Number NCT07292168
Lead Sponsor Kidney Cancer Research Bureau
Conditions
(from sponsor)		 Renal Cell Carcinoma Metastatic, Prostate Cancer Metastatic, Non-small Cell Lung Cancer Metastatic, Breast Cancer Metastatic, Head & Neck Cancer
Related terms Acrocephalosyndactylia, Breast Neoplasms, Head and Neck Neoplasms, Kidney Neoplasms, Lung Neoplasms, Neoplasm Metastasis, Prostatic Neoplasms
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov